This section provides background information related to the present disclosure which is not necessarily prior art. This section also provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.
Short bowel syndrome (SBS) is an often lethal medical condition characterized by the malabsorptive state of a patient who was born with intestinal atresia or has undergone massive small bowel resection to treat intestinal pathologies. The condition is challenging to manage and treat because of complications associated with parenteral nutrition, surgical bowel restructuring techniques, and transplants. As a result, mortality rates associated with SBS are as high as 38%. To provide an alternative to long-term parenteral nutrition reliance and surgical bowel lengthening, the present teachings provide a novel treatment device and method for short bowel syndrome based on mechanotransduction enterogenesis—the growth of tissue via application of a tensile load.
As one can appreciate, tissue-to-tissue and tissue-to-device attachment methods and devices are of great importance to a broad range of surgical applications including tissue approximation, wound closure, anastomoses, joint repair and replacement, osteo-distraction, long-gap esophageal repair, the prevention of stent migration, and the like. With respect to the tension-induced correction of short bowel syndrome (SBS), the ability to reliably and safely transfer load from an extending mechanism to the bowel wall is critical for success.
While the mechanotransduction approach to treating SBS is promising, the safe transfer of load from the extending mechanism to the bowel wall heretofore has remained a challenge. In prior research studies on mechanotransduction enterogenesis, two primary attachment mechanisms have been employed: 1) end abutting attachments—where a device is placed within an isolated segment of bowel whereby the ends of the bowel are sealed off to permit an internal device to press against the closed ends, thereby applying a tensile load—and 2) suture attachments—where sutures are used to surgically couple the device to the bowel wall. Although these attachment methods were suitable for research, they are not always reliable and may lead to other significant disadvantages that limit their use in clinical applications.
In order to realize the benefits of load-induced treatment in a clinical setting, there is a need for a tissue attachment device and method that attaches more reliably and safely. Ideally, a workable tissue attachment device and method would be able to achieve the following objectives:                transfer load from the extending device to the bowel wall without tissue slipping;        move freely through the bowel without inadvertently attaching to the bowel wall during implantation, removal, and other purposeful repositioning;        not cause ischemia (reduction of blood flood) on attached tissue, which may lead to compromised tissue;        not cause or require microscopic or macroscopic tearing, perforation, and/or other mechanical damage to tissue;        enable minimally invasive surgical procedures; and        minimize the surgical manipulation of remnant small bowel.        
Unfortunately, the end abutment and suture-based attachment methods described above do not meet many of these objectives, thereby limiting their clinical applicability.
According to the principles of the present teachings, an attachment system for attaching to an interior surface of a hollow member in both medical and non-medical applications is provided.
Although the present teachings will be described in connection with medical applications, and particularly in connection with the mechanical lengthening of soft tissue organs (e.g. bowels), it should also be understood that the principles of the present teachings may find utility in a wide variety of non-medical applications as will be discussed herein.
In some embodiments of the present teachings, an attachment system is provided for selectively attaching to an interior surface of a hollow member, which includes an expanding device selectively enlargeable from a first size to an enlarged second size, a friction enhancement disposed about the expanding device that is engageable with the interior surface of the hollow member when the expanding device is in the enlarged position, and a fenestrated decoupling system extending between at least a portion of the friction enhancement of the expanding device and the interior surface of the hollow member. The fenestrated decoupling system generally prevents contact of the friction enhancement with the interior surface of the hollow member when the expanding device is in the first size position and permits contact of the friction enhancement with the interior surface of the hollow member when the expanding device is in the enlarged position.
In some embodiments, the present teachings enable selective attachment of an elongation system to the inside of a generally tubular member, such as a soft tissue organ, which can be selectively attached and detached to permit application of longitudinal tensile loads while attached and permit slipping while detached. Conventional attachment systems are often permanent, instill injury to the soft tissue organ, and/or cannot apply significant longitudinal forces to facilitate tissue growth.
The present teachings were developed specifically to apply tensile loads and induce tissue growth in the small intestine, but are equally applicable to many other medical applications, including, but not limited to, esophageal growth, endovascular techniques, large intestine growth, blood vessels growth, other hollow organs growth, or endoscopy-type applications (where the application of traction is beneficial). The principles of the present teachings may also be applied to non-medical applications where attachment to and/or movement within tubular structures or irregularly shaped structures is desired. In each of these applications, the present teachings provide selective attachment and detachment capability.
While textured balloons have been used in the past for various endoscopic devices to hold a device in place within the intestines, the texture was necessarily limited to allow sliding of the device while the balloon was deflated. The innovation of the fenestrated decoupling system of the present teachings to selectively disengage the textured expanding device (e.g. balloon) enable a much deeper texture (i.e. increased frictional engagement) capable of applying much larger traction forces to the tissue. Without the fenestrated decoupling system of the present covering, the less deep mesh cannot provide sufficient traction against the soft tissue. The present teachings thus enable bowel or other organ extension/growth type uses and can greatly improve the capabilities of endoscopic devices to hold their positions, but still be easily moved and inserted when desired.
Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.
Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.